Regulatory NewsBREAK: HRSA Announces 340B Rebate Model Pilot Program

On July 31, 2026, the Health Resources and Services Administration (HRSA) announced (Notice) a revised 340B Rebate Model Pilot Program (Pilot) that would allow participating drug manufacturers to provide 340B discounts through retrospective rebates.  

Participating manufacturers would initially sell applicable drugs at non-340B prices and subsequently provide rebates to covered entities sufficient to achieve the applicable 340B ceiling price. Manufacturers may not unilaterally implement rebate models; any rebate approach requires agency approval.  

Participating manufacturers must provide prompt rebate payments within 10 calendar days of submission of a complete claim.

The Pilot requires unit-level rebate processing, allowing covered entities to receive rebates based on individual dispenses or administrations rather than waiting for full package utilization, as occurs under the current replenishment model.  

The Pilot accounts for starting inventory considerations to facilitate the transition from upfront discounts to rebates for a limited set of drugs.  

The Pilot also includes a 15-day implementation grace period for unreplenished accumulations.

Manufacturers must document and report denied claims, including the basis for each denial and the status of any associated dispute.

The Pilot defines a dispute resolution process to challenge denied claims, including specified timeframes for review and response.

The Pilot also includes data privacy and reporting requirements.

The Notice is effective immediately. Manufacturers interested in participating must submit pilot plans to HRSA by August 24, 2026, with approved arrangements taking effect January 1, 2027. HRSA noted that any agency approvals will be made by September 24, 2026. 

More on This Topic: 

• Notice
• Press Release

For questions, please reach out to Geni Tunstall.